Agency classClass IOur severity:Severe FDA (Devices)·Z-2619-2026·Announced 2026-07-08

DSAEK Pack-RX surgical kits recalled for bacterial contamination

Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. Per the rubric, FDA Class I recalls that do not meet Critical criteria (no reported deaths/serious injury) are scored as Severe (4).

Plain-English summary

Windstone Medical Packaging, Inc. is recalling DSAEK Pack-RX surgical convenience kits (Pack Number AMS12394B) distributed nationwide in Pennsylvania, Georgia, California, and Washington. The kits contain Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after the discovery of Paenibacillus phoenicis contamination during a routine sterilization dose audit. Approximately 1,080 kits are affected, identified by the following lot codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, and 241313.

Healthcare facilities that received these kits should stop using them immediately and contact Windstone Medical Packaging or Cardinal Health for instructions on product return or destruction.

The recalled product

Product: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kit
Hazard: bacterial-contamination
paenibacillus-phoenicis
Affected units: 1,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI none
Lot Codes: 237663
237901
237957
238041
238084
238085
238146
238197
238589
239157
239216
239286
239337
239386
239943
240269
240633
240705
240903

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · bacterial contamination